Kornimate/medical-research-clean huggingface dataset:
etanercept survival in elderly population

Conditions: Psoriasis

Summary: evaluate the 3-year survival of etanercept in patients over 60 years with psoriasis in moderate / severe plaque and the reasons that led to the abandonment. besides factors that might have had a positive or negative influence on adherence to treatment and analysis of efficacy (pasi 75) and safety will be identified. all variables were collected through retrospective review of medical records of patients dermatology unit are made.


Eligibility criteria:
inclusion criteria: * patients with moderate / severe psoriasis (with / without psoriatic arthritis,pas) defined by: pasi(psoriasis area and severity index)\> 10 and / or bsa(body surface area)\> 10% and / or dlqi(dermatology life quality index)\> 10 * pasi\> 10 and / or bsa(body surface area)\> 10% and / or dlqi(dermatology life quality index)\> 10 * over 60 years of age at the start of treatment * receiving etanercept at any time * available history in the dermatology exclusion criteria: * patients with insufficient clinical data in the medical record
role of cardiac computed tomography in optimising response to cardiac resynchronisation therapy

Conditions: Heart Failure

Summary: the purpose of this study is to determine if detailed scanning of the heart before biventricular device insertion will improve outcomes for heart failure patients.


Eligibility criteria:
inclusion criteria: 1. age \> 18, \<90 2. patients with moderate or severe heart failure ( nyha functional class ii-iv) due to ischaemic or non-ischaemic cardiomyopathy. 3. qrs duration \>120ms on 12 lead ecg 4. lvef \< 35% 5. lvedd \>55 mm 6. patients on optimum medical treatment for heart failure. the doses of these medications have been stable for 3 months. exclusion criteria: 1. patients with a cardiac or cerebral ischemic event within the previous three months prior to recruitment 2. patients who had had an atrial arrhythmia within one month prior to recruitment 3. patients with a systolic blood pressure of more than 170 or less than 80 mm hg 4. patients with a heart rate of more than 140 beats per minute 5. patients with severe renal failure (egfr \< 30) 6. patients with a history of allergy to iodine based contrast agents 7. predicted life expectancy \< 1 year 8. pregnancy
comparing pharmacodynamic and pharmacokinetic properties of insulin degludec and insulin glargine 300 u/ml at steady-state conditions in subjects with type 1 diabetes mellitus

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe. the aim of this trial is to compare pharmacodynamic (the effect of the investigated drug on the body) and pharmacokinetic (the exposure of the trial drug in the body) properties of insulin degludec and insulin glargine 300 u/ml at steady-state conditions in subjects with type 1 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * male or female aged 18-64 years (both inclusive) at the time of signing informed consent * subjects diagnosed (clinically) with type 1 diabetes mellitus at least 365 days prior to the day of screening * body mass index 18.5-29.0 kg/m\^2 (both inclusive) exclusion criteria: * subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to screening * smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)who is not able or willing to refrain from smoking or use of nicotine gum or transdermal nicotine patches during the in-patient period
a study to evaluate pre-operative hypofractionated radiation therapy in aged (≥ 70 years old) or "fragile" (≥ 65 years) patients with limb or trunk soft tissue sarcoma.

Conditions: Soft Tissue Sarcoma

Summary: this is a phase ii, multicenter, non-randomized study. the main objective is to evaluate the treatment with hypofractionated radiation therapy in neo-adjuvant situations on wound healing in a population of aged patients (≥ 70 years old) or ≥ 65 years of age defined as "fragile" and treated for soft tissue sarcoma. a maximum of 48 evaluable patients will be included in this study. the patients will receive an hypofractionated radiation therapy prior to conservative surgery. each patient will be followed for up to 3 years after the end of complete treatment (radiotherapy + surgery).


Eligibility criteria:
inclusion criteria: 1. patient with histologically confirmed soft tissue sarcoma of the limbs or trunk. 2. indication for neo-adjuvant or adjuvant radiotherapy. 3. patient aged ≥ 70 years with a performance status ecog ≤ 2 and/or aged 65 to 70 years with an ecog of 2 and identified by the investigator as "fragile". 4. patient affiliated to a social health insurance in france. 5. patient able to participate and willing to give informed consent prior performance of any study-related procedures. exclusion criteria: 1. retroperitoneal, orl and visceral sarcomas. 2. previous radiotherapy in the area. 3. metastatic disease. 4. concomitant or sequential chemotherapy. 5. patient requiring total surgery (amputation). 6. other cancer under treatment. 7. any condition or pathology contraindicating mri. 8. any psychological, familial, geographic or social situation, potentially preventing the provision of informed consent or compliance to study procedure. 9. patients included in another therapeutic interventional trial. 10. patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).

Keywords: soft tissue sarcoma limb soft tissue sarcoma trunk soft tissue sarcoma aged population "fragile" population hypofractionated radiation therapy
chloroquine outpatient treatment evaluation for hiv-covid-19

Conditions: Covid-19; HIV

Summary: clinical manifestations of covid-19 are poorly characterised in hiv co-infection, which may predispose to more severe disease. reducing hospitalisation and severe illness in this population has important individual and public health benefits. the investigators propose a pragmatic multi-centre, randomized controlled trial in south africa to evaluate the efficacy and safety of chloroquine or hydroxychloroquine to prevent progression of disease and hospitalisation amongst hiv-positive people with covid-19 not requiring hospitalisation at initial assessment.

the trial objective is to compare chloroquine (or hydroxychloroquine) versus standard of care for the primary endpoint of hospitalisation or death at 28 days. consenting adults who meet criteria for a covid-19 person under investigation and who are ≥18 years, known to be hiv-positive, not requiring immediate hospitalisation and are not at risk of cardiac toxicities related to the study drug will be enrolled. the total sample size will be 560 participants (280 in each arm).

Eligibility criteria:
inclusion criteria: * tested for covid-19 at a trial recruitment site as an outpatient; * age 18 years or older; * not requiring immediate hospitalisation; * mild disease, defined as respiratory rate \ 94%; * hiv-positive by rapid test or documented history; * suspected or confirmed covid-19; * signed informed consent. exclusion criteria: * covid-19 diagnosed \> 5 days prior to randomization; * active tuberculosis; * need for concomitant drugs that are contraindicated with the use of chloroquine/hydroxychloroquine; * qtcf interval \> 480 ms; * known glomerular filtration rate \< 10 ml/min; * known with glucose-6-phosphate dehydrogenase deficiency (g6pd); * previous adverse drug reaction to investigational product; * concurrent involvement in other research or use of chloroquine, hydroxychloroquine or any other 4-aminoquinolone or another experimental investigational medicinal product that is likely to interfere with the study medication. note: pregnancy and breastfeeding are not exclusions for entry
interpersonal psychotherapy for severely depressed inpatients

Conditions: Major Depression

Summary: we examined the hypotheses that severely depressed inpatients treated for 5 weeks with ipt-s plus pharmacotherapy have 1) a higher reduction in depressive symptoms and 2) higher response- and remission rates compared to pharmacotherapy plus cm. for the follow-up period (12 months) we hypothesized a better symptomatic and psychosocial longterm outcome and lower rates of relapse for patients initially treated with combination therapy.

a randomized controlled trial was conducted in 124 hospitalized patients with a dsm iv diagnosis of major depressive disorder comparing 5 weeks of interpersonal psychotherapy modified for depressed inpatients (ipt-s) plus pharmacotherapy versus medication plus intensive clinical management (cm). the study included a prospective, naturalistic follow-up 3- and 12 months after acute treatment in 97 of 105 treatment completers. the 17-item version of the hamilton rating scale for depression (hamd) served as the primary outcome measure.

Eligibility criteria:
inclusion criteria: major depression (single episode, recurrent or bipolar ii) according to the structured clinical interview for dsm iv (scid)and a score of ≥ 16 on the 17-item version of the hamilton rating scale for depression (hamd) exclusion criteria: (1) concurrent diagnosis of bipolar i disorder, primary substance abuse or dependency, mental disorder due to organic factors, and borderline or antisocial personality disorder, (2) psychotic symptoms, (3) severe cognitive impairment, (4) contraindications to the study medication, and (5) being actively suicidal
a research study looking at the comparability (bioequivalence) of two forms of semaglutide in two different pen-injectors in people with overweight or obesity

Conditions: Overweight; Obesity

Summary: the study will look at how two different forms of semaglutide reach and stay in the blood after injection. none of the two forms of semaglutide have been approved by the authorities to treat obesity, but it has been approved as a treatment for diabetes mellitus. participants will get 1 of the 2 forms of semaglutide - which one is decided by chance. participants will get the medicine as an injection under the skin of the belly using a pen-injector. the type of pen-injector is different for the two forms of semaglutide. the study staff will teach participants how to inject the medicine. participants will take an injection once a week and will get a total of 21 injections of study medication. the study will last for about 27-30 weeks. participants will have 25 study visits with the study doctor. for 2 of the visits, participants will stay in the clinic for 3 days and 2 nights. participants may have to stop the study if the study doctor thinks that there are risks for their health. women cannot take part if they are pregnant, breast-feeding or planning to become pregnant during the study period.


Eligibility criteria:
inclusion criteria: * male or female, aged 18-65 years (both inclusive) at the time of signing informed consent * body mass index (bmi) between 27.0 and 34.9 kg/m\^2 (both inclusive) * body weight between 70.0 and 130.0 kg (both inclusive) exclusion criteria: * female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method * any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol * inability or unwillingness to perform self-injection
a clinical study to evaluate the efficacy and safety of hlx07 combination therapy in patients with extensive small cell lung cancer

Conditions: Small-cell Lung Cancer

Summary: this study is conducted in patients with advanced metastatic small cell lung cancer (sclc). this study includes a single arm: the patients will receive hlx07 combination therapy with hlx10 and chemotherapy (carboplatin+etoposide) as first-line treatment. all of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent (whichever occurs first, hlx10 treatment up to 2 years).


Eligibility criteria:
inclusion criteria: * histologically or cytologically diagnosed with es-sclc (according to the veterans administration lung study group staging system) * no prior systemic therapy for es-sclc * major organs are functioning well * participant must keep contraception exclusion criteria: * histologically or cytologically confirmed mixed sclc * known history of severe allergy to any monoclonal antibody * known hypersensitivity to carboplatin or etoposide * pregnant or breastfeeding females * patients with a known history of psychotropic drug abuse or drug addiction * patients who have other factors that could lead to the early termination of this study based on the investigator's judgment
analysing peripheral skeletal muscle function before and after endobronchial valve treatment

Conditions: Emphysema

Summary: rationale: chronic obstructive pulmonary disease (copd) is characterised by a high prevalence of peripheral muscle dysfunction, which can have significant clinical consequences, including decreased exercise capacity, reduced quality of life, and even a higher mortality rate. reduction of lung hyperinflation using bronchoscopic lung volume reduction treatment with one-way endobronchial valves (ebv) is a minimally invasive intervention which improves exercise capacity and physical activity in patients with severe emphysema. this positive effect is also related to weight gain and alterations in body composition. the physiologic and structural adaptations of skeletal muscle function after ebv treatment has never been investigated before. objective: to investigate the physiological and structural adaptations of peripheral muscle function at a cellular level in response to ebv treatment. study design: a single center, prospective clinical trial with a single-arm pretest-posttest design. patients with severe emphysema who will receive a bronchoscopic lung volume reduction treatment are asked to undergo additional in-magnet exercise testing and muscle biopsies before and after placement of ebvs. study population: patients with severe emphysema who are scheduled to undergo ebv treatment. main study parameters/endpoints: the difference in quadriceps phosphocreatine concentration (pcr), quadriceps inorganic phosphorus concentration (pi), and quadriceps ph at rest, during progressive exercise, and recovery rate will be measured by 31p-mrs to assess the physiological effect of ebv treatment on skeletal muscle function and its bioenergetics. furthermore, we will perform a detailed histological and biochemical analysis of muscle fiber type composition, mitochondrial density, master regulators of muscle oxidative programming, and mitochondrial respiration before and after ebv treatment.


Eligibility criteria:
inclusion criteria: * patient is scheduled for a bronchoscopic lung volume treatment using one-way endobronchial valves; * patient read, understood and signed the informed consent form. exclusion criteria: * inability to perform a cycle ergometry test; * contraindications for undergoing a magnetic resonance imaging scan (e.g. claustrophobia, implanted cardiac devices); * body length \>190cm; * any anticoagulant therapy; * copd exacerbation 4 weeks prior to testing.
collaborative stepped-care and productive ageing program for older people with depressive symptoms

Conditions: Depressive Symptoms

Summary: the jockey club holistic support project for elderly mental wellness (jc joyage) has developed and implemented a collaborative stepped care model for older persons at-risk of or with depression in four districts in hong kong since 2015 (clinical trials identifier: nct03593889). results from jc joyage show that the collaborative stepped-care model is effective in improving older persons' mental wellness, and the specialised training and engagement of peer supporters are effective in building capacity in the community. the proposed impact extension programme lasts for four years (from 2020 to 2023), and the overall goal is to expand the jc joyage model to all 18 districts in hong kong, to provide integrated and evidence-based mental health services to older adults with subclinical depressive symptoms, with the hope of model adoption in regular service upon project completion.

this four-year extension project includes three main elements: 1) trainings, including different programmes for social services staff, mental wellness ambassadors, and peer supporters; 2) implementation of joyage service model: standardized collaborative stepped-care and peer support programmes for prevention and early intervention of depression in older adults; and 3) public awareness campaign: coordinated programmes to increase mental health literacy and raise public awareness. specific goals of the programmes through the above three elements include: 1. to implement jc joyage clinical protocol and guidelines to coordinate care among community mental health and aged care services centres for elderly mental wellness in 18 districts; 2. to engage vulnerable and at-risk older adults in the community through productive ageing activities and mental wellbeing self-management training; 3. to enhance the capacity of social service staff in handling elderly depression through specialized and infusion training and knowledge exchange; 4. to raise public awareness and elderly mental health literacy among family members, neighbours, community stakeholders, and the general public to encourage early detection/help-seeking on depressive risk of older adults; and 5. to establish evidence of the effectiveness and cost-effectiveness of jc joyage phase ii model.

Eligibility criteria:
inclusion criteria: * age 60 years or above; and * have depressive symptoms of mild level or above; and * able to give informed consent to participate exclusion criteria: * known history of autism, intellectual disability, schizophrenia-spectrum disorder, bipolar disorder, parkinson's disease, or dementia; and * (temporary exclusion criteria) imminent suicidal risk; and * difficulty in communication

Keywords: collaborative stepped care peer support productive ageing early case identification indicated prevention early treatment recovery oriented
comparison between hemitrapeziectomy and total trapeziectomy with ligament reconstruction and tendon interposition in trapeziometacarpal osteoarthritis ii-iii eaton-littler

Conditions: Trapeziometacarpal Osteoarthritis

Summary: 1. introduction: investigators think that surgery with preservation of healthy joints (hemitrapeziectomy) in trapeziometacarpal osteoarthritis without affecting sapho-trapezo-trapezoid joints, is better for scaphoid stability by preventing its collapse and thus preserving the stability of the carpus. 2. objectives and hypothesis: ligamentoplasty with partial trapeziectomy in grades ii-iii eaton presents better results in the pollicis-lateral pinch (key pinch) strength than ligamentoplasty with total trapeziectomy. main objective: to demonstrate using the dynamometer that the postoperative key pinch strength higher using ligamentoplasty with partial trapeziectomy in grades ii-iii eaton. secondary objectives: to measure the collapse of the first column of thumb using calibrated radiographic analysis. pain (e.v.a scale). range of motion (measured with goniometer). quality of life (disabilities of the arm, shoulder and hand questionnaire). 3. methodology: it is a single-center randomized trial, parallel-group, in which two types of surgical techniques (tt - tp) will be compared. patients will be randomized in this two techniques will be followed for one year, in routine clinical practice.


Eligibility criteria:
inclusion criteria: * patients with osteoarthritis in the trapeziometacarpal joint determined by the classification of eaton-littler (stages ii-iii) with trapeziometacarpal joint pain, loss of function, that were included in surgical waiting list and have accepted under informed consent, including the study. exclusion criteria: * patients with osteoarthritis eaton-littler (stage iv). * patients with huge affection of trapezium subchondral cysts and poor quality of trabecular bone. * cognitive impairment. * old fracture with impairment of the same extremity. * rheumatic active illness. * patients who withdraw their informed consent, or in case of impossibility of opinion by clinical status, whose legal guardians or close relatives to withdraw their informed consent to participate in the study. * patients who for any reason not related to the indication needed discontinue study participation or impossible to carry out assessments under more than two follow-up visits. * patients in whom it is considered that participation in the clinical study can be a prejudice, the physician responsible for patient care opinion.

Keywords: total trapeziectomy partial trapeziectomy ligamentoplasty
pulse oximeter and respiratory rate test

Conditions: Hypoxia; Hypercapnia; Hypocapnia

Summary: assessment of spry health's loop oximetry accuracy in profound hypoxia assessment of spry health's respiratory rate accuracy in normal conditions and profound hypoxia


Eligibility criteria:
inclusion criteria: * healthy adult willing to participate exclusion criteria: * wrist size outside the indicated use * low perfusion * smoking
quantification of side effects during hepatitis c therapy

Conditions: Hepatitis C

Summary: this study aims to assess the frequency and severity of adverse events during hepatitis c therapy with or without first generation protease inhibitors.

hepatitis c virus infection is one of the main causes of chronic liver disease worldwide with current estimates of approximately 130 - 210 million individuals (according to 3% of the world population) chronically infected with the hepatitis c virus. however, hepatitis c virus infections are among the most common causes leading to chronic hepatitis, liver cirrhosis and liver related death worldwide. the current standard of care is a combination of pegylated interferon and ribavirin (dual-therapy). since 2011, direct-acting antiviral drugs inhibiting viral protease are approved as an addition to the standard therapy (triple-therapy). the occurrence of adverse events as well as their severity generally depends on the therapy regimen and is influenced by type and dosage of medications. most common adverse events (affects up to 95% of patients) are fever, fatigue, headache, nausea, arthralgia, depression, skin reactions, neutropenia, and anemia. a more frequent occurrence of adverse events with triple-therapy compared to dual- therapy has become clear since it's introduction, particularly with regard to anemia, neutropenia, gastrointestinal discomfort, fatigue, dysgeusia, and skin reactions. how- ever, there is accumulating evidence for a more often appearance of infections and/or infestations in patients receiving triple-therapy. the medical consequence from adverse events is a reduction of quality of life and consecutively the loss of antiviral therapy adherence. thus, early recognition and immediate treatment of adverse events are crucial aspects in the success of antiviral treatment. aim of this study is to quantify reported adverse events with respect to therapy reg- imen (dual-therapy vs. triple-therapy) in patients who are treated at the department of internal medicine, division of gastroenterology and hepatology at the medical university graz. furthermore, a detailed review of international treatment recommendations, as well as an analysis of possible predictor parameters for the appearance of adverse events and treatment success is done.

Eligibility criteria:
inclusion criteria: * chronic hepatitis c * indication for a hepatitis c therapy exclusion criteria: * none